Postoperative Nausea and Vomiting Clinical Trial
Official title:
Effect of Remimazolam on Incidence of Postoperative Nausea and Vomiting Following General Anesthesia in High-risk Patients: a Multicenter, Double-blinded, Placebo-controlled Randomized Trial
Verified date | December 2023 |
Source | Peking University First Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial aims to explore whether the intraoperative use of remimazolam can reduce the incidence of postoperative nausea and vomiting (PONV) in high-risk patients. According to the Apfel's simplified score, patients with 3 or more of the following factors are at high risk of postoperative nausea and vomiting (PONV), i.e., women, non-smokers, history of PONV, and postoperative use of opioids.
Status | Completed |
Enrollment | 552 |
Est. completion date | April 22, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age =18 years old; 2. Scheduled to undergo elective surgery under general anesthesia; 3. Judged to be at high risk of postoperative nausea and vomiting. According to the Apfel's simplified score, patients with 3 or more of the following factors are at high-risk: women, non-smokers, history of PONV, postoperative use of opioids. Exclusion Criteria: 1. Refuse to participate; 2. Previous history of schizophrenia, epilepsy, Parkinson's disease or myasthenia gravis; 3. Severe liver dysfunction (Child-Pugh class C); 4. Severe renal dysfunction (dialysis required); 5. Patients of the American Society of Anesthesiologists (ASA) grade 4 and above; 6. Emergency surgery; 7. Continuously taking benzodiazepines for more than 1 week before surgery; 8. Any other circumstances that are considered unsuitable for study participation by attending physicians or investigators. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Hospital of the Ministry of Health | Beijing | Beijing |
China | Beijing YouAn Hospital, Capital Medical University | Beijing | Beijing |
China | Fuwai Hospital Chinese Academy of Medical Sciences | Beijing | Beijing |
China | Peking University First Hospital | Beijing | Beijing |
China | Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) | Hangzhou | Zhejiang |
China | The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang |
China | Suzhou Municipal Hospital | Suzhou | Jiangsu |
China | Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin |
China | Tongji Hospital, Tongji Medical College of HUST | Wuhan | Hubei |
China | Wuhan Puai Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital |
China,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of intraoperative awareness | Intraoperative awareness is assessed with the modified Brice questionnaire during PACU stay and on the first postoperative day | Up to 24 hours after surgery | |
Other | Incidence of dreaming during general anesthesia | Assessed with the modified Brice questionnaire on the first day after surgery. Record whether the patient can recall the content of the dream (divided into clear, unclear, and forget) and the impact of the dream on the patient's subjective feelings (divided into pleasure, normal, sad, and nightmares) | Up to 24 hours after surgery | |
Primary | Incidence of postoperative nausea and vomiting (PONV) within 24 hours following surgery | Nausea is diagnosed when the patient has gastrointestinal symptoms but does not vomit stomach contents. The severity of nausea is assessed using a digital subjective score scale (the scale ranges from 0 to 10, where 0 points represent no nausea, and 10 points represent the most severe nausea). Vomiting is diagnosed when the patient has gastrointestinal symptoms and retching or vomits gastric contents. Retching refers to the act of vomiting, but no stomach contents are vomited out. | Up to 24 hours after surgery | |
Secondary | Incidence of PONV within 48 hours after surgery | Nausea is diagnosed when the patient has gastrointestinal symptoms but does not vomit stomach contents. The severity of nausea is assessed using a digital subjective score scale (the scale ranges from 0 to 10, where 0 points represent no nausea, and 10 points represent the most severe nausea). Vomiting is diagnosed when the patient has gastrointestinal symptoms and retching or vomits gastric contents. Retching refers to the act of vomiting, but no stomach contents are vomited out. | Up to 48 hours after surgery | |
Secondary | Incidence of complications within 30 days after surgery | Postoperative complications are defined as new-onset medical events that are harmful to patients' recovery and required therapeutic intervention, i.e., grade II or above on the Clavien-Dindo classification. | Up to 30 days after surgery | |
Secondary | Subjective sleep quality score within 3 days after surgery | Subjective sleep quality was evaluated with the NRS (an 11-point scale where 0=the worst night sleep and 10=the best night sleep). | Up to 3 days after surgery | |
Secondary | Incidence of emergence delirium (ED) | Delirium is assessed with the Confusion Assessment Method for the Intensive Care Unit. The assessments are performed at 10 minutes and 30 minutes after admission to the post-anesthesia care unit (PACU), or before leaving the PACU. | Up to 30 minutes after surgery or during the stay in PACU | |
Secondary | Incidence of delirium within 3 days after surgery | Delirium is assessed with the Three-dimensional Confusion Assessment Method (3D-CAM) twice daily (between 8-10 am and 18-20 pm) during the first 3 days after surgery. | Up to 3 days after surgery | |
Secondary | Length of stay in hospital after surgery | Length of stay in hospital after surgery | Up to 30 days after surgery |
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